Specialty Minerals Incorporated
Form 483 issued August 22, 2019 · Adams, Massachusetts
- Investigator
- Nancy M. Espinal
- Observations
- 3
- Pages
- 4
- FEI number
- 1214544
In short: On August 22, 2019, FDA issued a Form 483 with 3 observations to Specialty Minerals Incorporated in Adams, Massachusetts (FEI 1214544). The investigator was Nancy M. Espinal. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (2×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory control records do not include complete data derived from all tests conducted to ensure compliance…
- 02
Procedures describing the handling of written and oral complaints related to drug…
- 03
Investigation into customer complaint…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmSpecialty Minerals Incorporated history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Minerals Incorporated?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Specialty Minerals Incorporated?
Nancy M. Espinal is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Specialty Minerals Incorporated inspected by FDA?
This Form 483 is dated August 22, 2019.
How do I get the full Form 483 for Specialty Minerals Incorporated?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.